AN OBSERVATIONAL POST-AUTHORIZATION MODIFIED PRESCRIPTION-EVENT MONITORING SAFETY STUDY TO MONITOR THE SAFETY AND UTILIZATION OF EXENATIDE ONCE WEEKLY (BYDUREON®) IN THE PRIMARY CARE SETTING IN ENGLAND

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Modified PrescriptionEvent Monitoring

Study drug and medical condition

• Name of medicine:
  BYDUREON
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Type 2 diabetes mellitus patients newly initiated on treatment with exenatide once weekly in the primary care setting.; Patients, for whom a study questionnaire containing useful information has been returned, were eligible for inclusion in the evaluable patient study cohort.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Type 2 diabetes mellitus patients
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  To provide timely information to quantify the incidence rate of the important identified risk of acute pancreatitis in the first 12 months after starting treatment.
• Outcomes:
  The incidence rate of the important identified risk of acute pancreatitis in the first 12 months after starting treatment, 1. The baseline health profile of patients on treatment with exenatide in the primary care setting, the treatment they received, and by whom2. The risk profile of events reported in the 12 month observation period in the overall cohort and in special populations (arising from contraindications, precautions etc.)
• Data analysis plan:
  PEM methodology provides a numerator (the number of reports of an event) and a denominator (the number of patient-months at risk), both collected within a known time frame. This allows for the calculation of risk (percent of total valid cohort exposed) and incidence densities (ID, person-time incidence rates) for each event. Such analyses will be performed using ‘Higher-level’ event terms from the MedDRA dictionary.In addition, the incidence rate of acute pancreatitis will be explored in exenatide naïve and switcher patients by estimating the hazard rate of this event over time. The null hypothesis that the hazard rate of acute pancreatitis in patients exenatide will be constant during the 12 month exposure period following the start of treatment will be tested by fitting parametric time to event models (e.g. Weibull).Descriptive summary statistics will also be employed to present such as demographic data.